health of newborn exposed to TNFalfa inhibitors [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Development (growth and health) of newborns exposed to TNFalfa in utero / early in pregnancy.

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Preconceptional Counselling in Active Rheumatoid Arthritis

Official Title ICMJE

Preconception Counselling for Women With a Pregnancy Wish and High Disease Activity of Rheumatoid Arthritis (RA) With a Prospective Observational Study Addressing Health Issues of Mother and Child.

Brief Summary

Fertile women postpone their wish to conceive when they have active disease activity of rheumatoid arthritis (RA). Since treatment options are restricted and inappropriate in many women with high disease activity, an observational study among fertile women with a wish to conceive, treated with a regular care program, among which a consultation of gynecologist and a rheumatologist will be provided, in order to enlarge the chance of conceiving. Treatment options will be discussed with the patient, and when needed TNFalfa inhibitors will be prescribed until 20th week of gestation. Follow-up of disease activity of RA, complications of treatment, and pregnancy outcome of women are part of the observational study. As well as the observational study on the newborn on activity of TNFalfa inhibitors in (cord)blood, growth analysis and general health.

Detailed Description

Not Provided

Study Type ICMJE

Observational

Study Design ICMJE

Observational Model: CohortTime Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

blood of mother before, during and after pregnancy cordblood of newborn blood of newborn

Sampling Method

Non-Probability Sample

Study Population

Women with high disease activity of RA and a pregnancy wish.

Condition ICMJE

Rheumatoid Arthritis

Pregnancy

TNFalfa Inhibitors

Preconceptional Counselling

Disease Activity

Intervention ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.